Disposable Two-Part Orthotic Foot Support Strap System And Method

ABSTRACT

A method for treating plantar fasciitis and foot pain utilizes a pre-cut sole support strap and an arch support strap formed of flexible woven material having an adhesive layer on an underside surface that are adhered to a foot individually or in combination. The sole strap is adhered to the skin surface along the sole from the ball of the foot to the heel and the back and lateral sides of the heel, and provides stability and support to the foot and, when subjected to forces induced during walking, absorbs tensile loads and stresses to prevent damage to the plantar fascia by reducing tensile stress carried by the plantar fascia. The arch support strap is adhered transversely over the sole support strap and arch of the foot to maintain the sole support strap in engagement with the sole of the foot and provide additional support and stability.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of and claims priority of U.S. patentapplication Ser. No. 13/365,237 filed on Feb. 2, 2012, which is aContinuation-In-Part of and claims priority of U.S. patent applicationSer. No. 12/876,060, filed on Sep. 3, 2010, which claims priority ofU.S. patent application Ser. No. 11/165,304, filed on Jun. 23, 2005, nowU.S. Pat. No. 8,216,162, which is a Continuation-In-Part of U.S. patentapplication Ser. No. 10/817,172 filed Apr. 2, 2004.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to orthopedic devices for the foot and,more particularly, to a disposable two-part non-resilient, non-stretchorthotic foot support strap system having a sole support strap memberand an arch support strap member that can be adhesively applied to afoot individually or together for reducing tensile loads and stressesand providing anatomical support and stability to the musculoskeletalsystem and the sole, arch and heel of a foot of a user, and relief fromplantar fasciitis.

2. Background Art

Many people suffer from excessive foot strain and conditions such asplantar fasciitis. Plantar fasciitis often occurs in individuals whoundergo long periods of weight bearing or undergo sudden changes ofweight bearing. Other factors that may lead to this condition includeobesity, weight gain, jobs that require a lot of walking on hardsurfaces, shoes with little or no arch support. A description of thefoot structure leading to this condition is provided as background forunderstanding the present invention.

A dissected bottom view of a human foot 100 is shown in FIG. 1 toillustrate some of the parts of a plantar fascia 110 located in thebottom of the human foot 100. The plantar fascia 110 extends from aboutthe location of the heel 101 to about the location of the ball 102 ofthe foot. The plantar fascia 110 includes medial plantar fascia 120,superficial tracts 130, a central component of the plantar fascia 140,and a lateral component of the plantar fascia 150. The separate portionsof the plantar fascia 110 act as a shock absorber while walking andtransfer tensile forces along the bottom of the foot 100.

A cross sectional side view of tissue and bone structure in the humanfoot 100 is shown in FIG. 2. The human foot 100 includes the plantarfascia 110, a plantar calcaneus 160, a talus 162, a navicular 164, acuneiform 166, a cuboid 168, metatarsals 170, phalanges 172, a sesamoid174, a fat pad area 176, and an outer skin surface 178. As seen from theside, the plantar calcaneus 160, the talus 162, the navicular 164, thecuneiform 166, the cuboid 168, the metatarsals 170, and the sesamoid 174form what resembles the shape of an arch. This shape is commonlyreferred to as the longitudinal arch. Another arch commonly referred toas the transverse arch (metatarsal) also exists in about the same areain a perpendicular direction that runs laterally across the width of thefoot.

The plantar fascia 110 provides anatomical support to the foot as itserves the vital role of maintaining the shape of the two anatomicalarches of the foot, the transverse arch and the longitudinal arch. Asillustrated in FIGS. 1 and 2, the plantar fascia 110 runs across thebottom of the foot 100 from the heel 101 to the ball 102 and spreads outacross the width of the foot 100. As longitudinal and lateral tensilestresses are produced in the bottom of the foot 100, the plantar fascia110 absorbs the tensile forces and maintains the shape of the twoanatomical arches.

For example, while standing or while in motion, forces experienced bythe foot 100 act in a direction which tends to flatten the arches. Thestress line 300 in FIG. 2 shows an approximation of the line of forcestransferred through foot 100 during typical motion. As shown in FIG. 2,the stress line 300 resembles the shape of an archer's bow. The plantarfascia 110 running along near the bottom surface of the foot 100 isanalogous to a string in the archer's bow. Forces that tend to move theends of the bow apart increase tension on the string. FIG. 2 also showsa sole support strap member 10 and an arch support strap member 20 ofthe present two-part non-resilient, non-stretch orthotic foot supportstrap system, illustrated somewhat schematically and with a greaterthickness for visibility, attached to the sole of the foot, and will bedescribed hereinafter.

The walking gait cycle is broken down into 3 different phases:

(1) Contact phase: The outside of the heel hits the ground. Just afterthe heel strikes, “pronation” occurs. Pronation is when the footflattens out and the ankle rolls inwards. At the same time, the lowerleg rotates inwards from the knee down. The pronated foot is flexibleand loose, serving as a shock absorber and allowing it to adapt to theground just stepped on. The contact phase continues until the foot iscompletely flat on the ground.

(2) Midstance phase: The foot is flat on the ground and in this part ofthe gait cycle the body weight passes over the foot as the body comesforward. This is where the foot supports the body weight. The midstancephase is the part of the gait cycle where an abnormally functioningfoot, such as an over-pronated foot (fallen arches) or an over-supinatedfoot (high arch foot) will typically manifest its problems. This phaseends as the body weight passes forward eventually forcing the heel torise off the ground. At this stage “supination” occurs and the oppositeto pronation happens: the muscles tighten and the foot becomes a rigidlever for the leg muscles to pull against. Rigidity in the foot shouldoccur as the foot is propelled forward towards the next step. Withsupination, the foot rolls outwards and the lower leg rotatesexternally.

(3) Propulsion phase, also known as toe-off or lift-off: This is wherethe foot pushes off the ground to propel the body forward. Body weightis picked up by the ball of the foot and lastly the weight is absorbedby the big toe as you push off with that foot.

It is important to understand that both pronation and supination arepart of a normal walking pattern. Pronation (rolling inward) acts as ashock absorbing process and supination (rolling outward) helps to propelthe foot forward

As forces on the foot attempt to flatten the arches during the footcontact phase of the gait cycle, the plantar fascia is stretched andtension on it is increased. During the propulsion phase (toe-off orlift-off) of the gait cycle the foot is used as a lever. During thisphase, as the heel is raised from the ground surface, tension in thefascia often reaches its peak. A windlass mechanism formed by the fasciaand its connection to the toes contributes to this increase in tensionduring the toe-off or lift-off (i.e. propulsion phase). The moreaggressive the propulsion phase (e.g. during a sprint) the higher thepeak stresses in the fascia.

The plantar fascia 110 is thick and essentially inelastic. If thetension on the plantar fascia 110 becomes excessive, the plantar fascia110 may be damaged or injured and produce a condition called plantarfasciitis. Plantar fasciitis is a painful medical condition resultingfrom inflammation of the plantar fascia 110. Overstressing the plantarfascia 110 may produce tears in the plantar fascia 110 or separate theplantar fascia 110 from bone and other surrounding materials. Tearingand separation of the plantar fascia 110 produces inflammation whichcontributes to the intense pain experienced by plantar fasciitissufferers, particularly after periods of rest. Frequently, the inflamedareas 305 are along the arch of the foot 100 and most often near theheel 101 of the foot as shown in FIG. 2, where the fascia has itssmallest cross-sectional area.

Plantar fasciitis may be quite debilitating in that everyday activitiessuch as walking and standing may be very painful. Typical treatments forplantar fasciitis may involve oral anti-inflammatories, ice packs,bedrest, stretching, steroid injections, night splints, wedge-shapedarch supports and compressive arch wraps. Even with these treatmentoptions being employed many suffer in pain for periods of months.Plantar fasciitis cases extending beyond six months are not uncommon.The primary symptom is pain typically in the heel, experienced duringthe first few steps in the morning or after periods of rest. This painis the result of inflammation accumulation in response to damaged tissue(i.e. micro-tears in the fascia). This inflammation which accumulatesduring rest, applies direct pressure to the damaged fascia andassociated soft tissue, as one begins to stand, bear weight, or walk(i.e., apply load to the foot). The pain is often described as feelinglike and ice pick in the heel. The pain is often described as feelinglike and ice pick in the heel. The initial pain typically lessens aftera few minutes of weight bearing as the fluid is pushed back into thesurrounding tissue. The pain will continue to reoccur as long as damageto the fascia is allowed to continues or is prevented from healing byre-occurring stress. In extreme cases, treatment of plantar fasciitismay culminate in expensive and invasive corrective surgery. Plantarfasciitis is often experienced in only a single foot.

To gain access to the plantar fascia, surgeons may perform either anendoscopic procedure requiring small incisions or conventional directvisualization requiring the underside of the foot to be opened up. Bothof which are painful, scars may result, and recovery time may be fromweeks to months.

Improper treatment of plantar fasciitis may lead to other medicalproblems. For example, if inflammation near the heel is allowed tocontinue for a long period of time, calcium deposits may build-up in thedamaged region. As the calcium builds-up, bony outcroppings, commonlyreferred to as “heel spurs” may develop in the heel. The longer theplantar fascia remains inflamed around the heel, the stronger theconditions are for the development of heel spurs. Protrusion of the heelspurs into the surrounding tissue may result in a cycle of irritation,inflammation, and pain known as heel spur syndrome. Heel spur syndromeis commonly treated with a surgical procedure requiring removal of theheel spurs from within the foot. An endoscopic procedure is typicallynot used for removal of heel spurs and open surgery is typicallyrequired. Recovery time from such surgery may range from weeks tomonths, during which time the patient has to curtail the amount ofstress placed on the foot.

A common example of non-surgical treatment for plantar fasciitis ismedical personnel strapping strips of adhesive tape to the bottom of aninjured foot. Strips of tape are applied at various angles across thebottom of the foot. The adhesive tape is sold on rolls and is difficultto remove from the rolls and must be customized for applicationaccording to the imagination and skill of the person applying the tape.Typically, the tape cannot be effectively applied by the patient to thepatient's own foot and usually requires application by anotherindividual or a trained medical technician. The person applying the tapemust cut off a section of the tape from a roll, cut the length of tapefurther into a therapeutic shape, and apply it to the patient. Thecutting, shaping and positioning (tensioning) of the tape piece are leftto the complete discretion of the person applying the tape, and it is atrial and error process. Even a trained medical technician must estimatea position, length, shape and degree of tension that will cause asubjective improvement in range of motion and pain relief in thepatient. If the tapes are stretchable, this further complicates theapplication and decreases the likelihood of consistent and repeatableself-application. Care must also be exercised during the application ofthe tape to avoid blister-causing wrinkles in the tape and otherproblems. The tape, when subject to the cyclic tensile loads, looseseffectiveness quickly as the materials elongate and the glue layers slipor creep. Multiple layers of material, glued to each other increase theopportunity for each or any of the glue layers to allow slippage as hightensile loads are applied. As the patient walks with the taped foot, thetape often works loose and stretches with time. Consequently, taping thefoot is cumbersome, inefficient, and ineffective in preventing excessivestretching of the plantar fascia.

A popular commercially available high-stretch elastic adhesive tapeknown as KINESIO TEX™, is manufactured by Kinesio Co., Ltd. of Japan anddisclosed in U.S. Pat. Nos. 5,861,348 and 7,902,420. This elastic tapeis designed for maximum range of motion and provides 140% elasticity(about same as basic elasticity found in skin and muscles), allowing itto work with the body. It does not limit range of motion and ineffectivein preventing excessive stretching of the plantar fascia. It is sold inrolls and also has the same disadvantages and tapping difficulties ofother adhesive tapes as discussed above.

Another example of non-surgical treatment for plantar fasciitis is theuse of elastic compression sock worn over the patient's foot or anelastic bandage or band worn around the mid-foot. These elastic devicesexert compressive forces along the longitudinal and transverse axes ofthe patient's foot. While some patients may be willing to wear theseelastic devices, they are inconvenient and cumbersome. In order to beinstalled on the foot, these elastic devices must be stretched to fitover the heel and toe or wrapped around the mid-foot. Because they areelastic, they allow the foot to move and stretch. Thus they have limitedeffectiveness in limiting the tensile stress on the plantar fascia,particularly during the propulsion phase of the gait cycle, as they donot limit deformation of the foot structure under load. Consequently,the plantar fascia may still be subjected to excessive tensile forcesduring the critical heeling process. Re-subjecting the plantar fascia totensile forces before it has completely healed may re-aggravate damagedor injured portions of the plantar fascia and undermine the healingprocess. In addition, these elastic devices are meant to be wornmultiple times and may require regular cleaning to avoid odors and footinfections. Also, they may not fit inside a shoe while being worn andmay be considered unsightly or become contaminated while walking aroundwithout shoes.

DEFINITION OF TERMS

Before discussing other methods and existing foot support devices fortreatment of foot disorders, it is believed that a definition ofterminology and nomenclature used in the art would helpful in order tofacilitate a better understanding of the significant differences andadvantages of the present invention over existing orthotic andnon-orthotic devices. The following terms, as used herein, have thefollowing meanings.

With regard to materials, a “woven” fabric is that class of fabricswherein involves the interlacing or interweaving of two sets of threadsat right angles (perpendicular) to each other: the warp (lengthwisethreads) and the weft (crosswise threads inserted over-and-under thewarp threads). A woven fabric only stretches in the bias directions (45degrees to its warp and weft threads). In contrast, a “non-woven” fabricis that class of fabrics wherein fibers or threads are matted together,usually in a random or non-directional manner, and are not held in placeby interweaving. Felt and cardboard are examples of non-woven materials.The important technical difference between a woven and non-woven fabricis their tensile strength (i.e., resistance to elongation). Wovenfabrics can have much higher tensile strength and resistance todeformation or elongation than that of non-woven fabric of the same GSM(Grams per Square Meter). The GSM is a scale for the weight of the sheetof fabric, paper, etc., which also provides some indication of itsthickness. The term “microfiber” commonly refers to any fiber withstrands less than 1 denier, or about half as thick as a strand of silk.Some microfiber fabrics use strands that are only 10 microns indiameter, or about one-tenth as thick as a human hair. “Denier” is theunit of measure for fibers that indicates their fineness.

With regard to thickness, the term “mil” is a unit of length orthickness, equal to one one-thousandth ( 1/1000) of an inch or 0.001″.For example, 2 mils is equal to 0.002″ ( 2/1000″). A “mil” is not thesame as a “millimeter”. In contradistinction, the term “millimeter”,abbreviated “mm”, is a unit of length or thickness, equal toone-thousandth of a meter or equal to thirty-nine thousandths ( 39/1000)of an inch. For example, 1 mm is equal to 0.039370 inches (approximately3/64″), and 2 mm is equal to 0.078740 inches (approximately 5/64″). 1mil is equal to 0.0254 millimeters (mm), and 1 millimeter (mm) is equalto 39.37007874 mils. As an example to compare the different thicknessmeasurements; a sheet of standard 20 lb wt. copy paper and a commonpostage stamp are each about 0.1 mm (equal to 4 mils or 0.004 inches)thick, and a conventional postcard is approximately 0.178 mm (equal to 7mils or 0.007 inches) thick.

With regard to material properties, the terms “resilient” and “elastic”refer to a material capable of regaining its original shape or positionafter being deformed elastically such as by bending, stretching,compression, or other deformation. “Deformation” is an alteration ofshape, as by pressure or stress. “Resilience” is the capability of astrained body to recover its size and shape after deformation causedespecially by compressive stress. The term “elasticity” is the physicalproperty of a material that returns to its original shape after thestress (e.g. external forces) that made it deform is removed. Therelative amount of deformation is called the “strain”. The term“elongation” means the state of being elongated or lengthened. The term“stretch” means the elongation, lengthening, widening, or distending ofa material under an applied load.

The term “modulus of elasticity” is the mathematical description of anobject or substance's tendency to be deformed elastically (i.e.,non-permanently) when a force is applied to it, more particularly, theratio of the stress applied to a material to the resulting strain withinthe elastic limit, also known as “elastic modulus” or “tensile modulus”.The term “tensile strength” is the measure of the ability of material toresist a force that tends to pull it apart. It is expressed as theminimum “tensile stress” (force per unit area) needed to split thematerial apart expressed as “psi” (lbs per square inch). It can bereported just as a force or as a force per unit width. Dimensionsmeasured in the cross-machine (CD) direction are referred to as “width”dimension, while dimensions measured in the machine direction (MD) arereferred to as “length” dimensions.

With regard to pressure sensitive adhesives (PSAs), the term “tack” isthe property of an adhesive that enables it to instantly form a bondwhen brought into contact with another surface. The term “tack force”,also called “tack strength”, is the maximum force required to separatethe bonded surfaces. “Adhesion” (peel adhesion), refers to how well thetape sticks to a surface. Usually measured in ounces of pull (force)required to remove a one-inch wide strip of tape from a steel plate(i.e., adhesion to steel), and expressed in ounces/inches. “Peelstrength” is measured as a force required to remove a standard PSA stripfrom a specified test surface under a standard test angle (e.g., 90° or180°) under standard conditions. Pressure sensitive adhesives (PSAs) maybe “removable” or “permanent”. “Low-tack” adhesives have low adhesionproperties and are easily applied and removed (i.e. Post-It® notes) andgenerally can not support much weight, “Medium-tack” adhesives have highadhesion properties but are removable and repositionable, and“high-tack” adhesives are typically considered to be a relativelypermanent bonding adhesive. Foil tape for HVAC duct work is an exampleof a permanent adhesive application.

The ASTM (the American Society for Testing and Materials), now namedASTM International, is an international standards organization thatdevelops and publishes technical standards and testing methods for awide range of materials, including various classes of pressure sensitiveadhesive tapes. Such testing methods include Peel Adhesion, ShearAdhesion, Tensile Strength, Breaking Strength, Elongation, etc. Forexample, the average tensile strength in both the machine andcross-machine directions of each roll of tape shall be not less than 25lbs/in (4.37 N/mm) of width; the average peel adhesion strength of eachroll of tape shall be not less than 3.75 lbs/in (0.66 N/mm) of width.The average peel adhesion strength at a 180° angle of each roll of tapeshall be not less than 3.75 pounds per inch (0.66 N/mm) of width oftape.

With regard to medical devices, medical dictionaries define a “splint”as a rigid or flexible appliance for fixation of displaced or movableparts (Dorland's Medical Dictionary for Health Consumers, © 2007 bySaunders); and an orthopedic device for immobilization, restraint, orsupport of any part of the body. It may be rigid or flexible (Mosby'sMedical Dictionary, 8th edition. © 2009, Elsevier). An “orthopedicbrace”, also known as an “orthosis” or “orthotic”, is a device used to:immobilize a joint or body segment, restrict movement in a givendirection, assist movement generally, reduce weight bearing forces for aparticular purpose, or otherwise correct the shape and/or function ofthe body to provide easier movement capability or reduce pain.

An “arch support” is an orthopedic shoe insert appliance having a moldedshell placed inside a shoe to provide underside support for the foot.The molded appliance is flexible enough to provide comfort and rigidenough to support the arch of the foot. The shell can be custom milledto fit individual feet using a medical foot casting system, or genericshapes and sizes can be purchased based on foot size and arch height.Arch supports are commonly confused with another type of shoe insertknown as “insoles”, which offer added resilient padding for shockabsorption.

As used herein in conjunction with the present invention, the term“orthotic” means a device for supporting and immobilizing a weak orinjured joint or body segment, restricting movement in a givendirection, assisting movement generally, reducing weight bearing forces,and improving the function of the joint or body segment to provideeasier movement capability or reduce pain. The term “strap” means a longnarrow flat strip of a flexible material used for securing, holdingtogether, or wrapping. The term “disposable” means for use in a singlecontinuous one-time application and treatment followed by removal anddisposal, rather than for removal and re-use for additional or multipleapplications. The term “non-resilient” means a non-cushioning materialnot capable of being deformed elastically, elongated, lengthened,widened, or distended by stretching or compressed by pressure or stressunder an applied load. The term “inelastic” means a material not capableof being deformed elastically, elongated, lengthened, widened, ordistended by stretching under an applied load or stress. The term“flexible” means capable of conforming to the shape and contours of thesurface to which it is applied, and being flexed repeatedly withoutdamage.

As used herein in conjunction with the present invention, the term“non-stretch” woven material means a woven material wherein both thewarp (lengthwise) and weft (crosswise) threads are substantiallyinelastic; consequently, the fabric material is substantiallynon-stretchable beyond its original dimensions in a longitudinal andtransverse direction. More specifically, a woven material which exhibitsbetween 0% to 3% elongation along its longitudinal and transverse axiswhen adhered to a user's foot and subjected to applied foot loads andstresses during the phases of a walking gait cycle. The term “preformed”as used herein in conjunction with the present invention, refers to anobject that has been formed during its manufacture into the condition orshape in which it is intended to be used prior to its use by an enduser. This is in contrast to a sheet, strip, or roll, of material whichrequires cutting or shaping by an end user prior to its use.

As used herein in conjunction with the present invention, the term “mil”means a unit of length or thickness, equal to one one-thousandth (1/1000) of an inch or 0.001″. 1 “mil” is equal to 0.0254 millimeters(mm) and thus is significantly smaller than 1 “mm”, and should beclearly distinguished over the terms “millimeter” and “mm”, which is aunit of length or thickness, equal to one-thousandth of a meter or equalto thirty-nine thousandths ( 39/1000) of an inch. 1 “mm” or “millimeter”is equal to 39.37007874 “mils”, or 0.039370 inches (approximately 3/64″)and, thus, is significantly larger than 1 “mil”. As used herein inconjunction with the present invention, the term “ultrathin” means verythin; more specifically having a thickness less than 1 mm (less than0.0394 inches).

Examples of Existing Orthotic Devices

There are many arch supports, insoles, cushions, and other devices whichmay be placed in shoes and merely sit under the arch of the foot toprovide comfort or correct foot deformities, but do not restrict footmovement and are incapable of limiting plantar fascia stress during theentire walking gait cycle. These devices are simply ineffective inlimiting tensile stress in the fascia as the heel lifts from the groundsurface to propel the body forward.

There are also several patents that are directed toward various orthoticdevices, arch supports, insoles, cushions, and other devices which areworn on, attached to, or stretched over a user's foot for preventing ortreating foot injuries but are not effective in stabilizing the foot orreducing tensile stress on the plantar fascia during the propulsionphase of the gait cycle when the heel is elevated above the groundsurface, or limiting deformation of the foot structure under load, andthus, have limited effectiveness in limiting tensile stress on theplantar fascia.

Domenico, U.S. Pat. No. 3,584,622, discloses a support member designedto prevent ankle injuries that is formed of flexible sheet materialwhich includes a foot receiving member conforming generally in shape tothe rear portion of a foot to receive the rear portion of a wearer'sfoot and cover the ankle, and stirrup portions extending upwardly fromthe foot receiving member to contact opposite sides of the wearer's leg,above the ankle. The inner surfaces of the foot receiving member andstirrups are provided with an adhesive coating for coupling the supportto the foot and leg of a wearer. No part of the foot receiving memberintrudes into the area of the calf muscles of the wearer, so thatrestriction of movement of the Achilles' tendon is avoided. Also, nopart of the foot receiving member extends forwardly beyond themetatarsus (the middle part of the foot that forms the instep) of thewearer's foot, and the forward and upper portions of the foot receivingmember are open to avoid restriction of desired foot movement. Thisdevice does not extend to the ball of the foot, allows movement of theAchilles' tendon, and allows foot movement, and would be incapable ofprotecting the plantar fascia from excessive stress during the phases ofa walking gait cycle.

Roth, U.S. Pat. No. 5,840,053, discloses a supportive device for thelongitudinal arch of the foot that applies a compressive force aroundthe mid-foot comprised of a fabric-coated elasticized strap enclosing aspecially designed pad of rubberized material. The strap is wrappedsnugly around the longitudinal arch with the enclosed pad strategicallyplaced under the longitudinal arch exclusively outside the lateralregion of the plantar portion of the longitudinal arch, to provideoptimum arch support and secured by a VELCRO-type fastener strip. Therubberized pad substantially regains its original thickness aftercompression for absorbing energy and defending against shock, thelongitudinal axis of the pad is approximately perpendicular to thelongitudinal axis of the foot, and has a tapered portion disposed fromthe longitudinal axis of the foot toward the medial region of thelongitudinal arch to minimize effects of pronation (rolling inward ofthe foot and ankle).

Examples of Existing Non-Orthotic Devices

There are also several patents that are directed toward variousnon-orthotic devices known in the art that are worn on, or attached to,a user's foot that merely provide a cushion for comfort or protect thefoot from contact with floor surfaces of indeterminate cleanliness andtemperature. These types of devices do not limit deformation of the footstructure during the phases of the walking cycle and, thus, areincapable of or ineffective in limiting tensile stress on the plantarfascia during the walking phases.

For example, Burgess, U.S. Pat. No. 6,640,465, discloses a lightweightremovable and disposable foot protector that protects the wearer's footwhen walking across surfaces that may be unsanitary, cold, wet, hot,slippery or otherwise undesirable. The foot protector includes aresilient sheet member having a shape generally matching a shape of asole of a foot and a size generally corresponding to a size of the foot.The resilient sheet member has a foot-contact surface with a tackadhesive layer on at least a portion of the foot-contact surface. Theresilient foot protector allows increased mobility of the foot whenadhered thereto. The thickness of the foot protector is in the range ofabout 1 mm (equal to 39.370 mils or 0.039 inches or approximately 3/64″,to about 5 mm (equal to 196.850 mils or 0.197 inches or approximately13/64″, a little over 3/16″), with a preferred thickness of about 2 mm(equal to 78.740 mils or 0.079 inches or approximately 5/64″, a littleover 1/16″), to provide enough resilience, or cushion effect, to providecomfort to the foot of the wearer. Burgess teaches that the adhesive isa relatively low-tack adhesive, for example, adhesives used inBAND-AIDS™, POST-IT NOTES™, feminine pads, and the like, which is stickyenough to hold the foot protector against the foot, but allows easyremoval of the foot protector from the sole of the foot. Burgess teachesthat the easier it is to remove the foot protector from the sole of thefoot, the more the wearer can experience the comfort level of aconventional slipper. Burgess also teaches that the resilient sheet maybe formed by a corrugated sheet interposed between two flat sheetmembers, such as cardboard, or other corrugated materials, such ascorrugated plastics, or formed by a fibrous layer or foam rubber andthat the fibers of the layer may be synthetic fibers, such aspolypropylene fibers, or natural fibers, such as paper or cloth fibers;or a multi-layered resilient foam rubber layer or fibrous layersandwiched between external layers of synthetic or natural material,Preferably, the fibers are randomly oriented (i.e. non-woven) to providea good degree of resilience and flexibility. An exemplary material is aspunbond polypropylene, such as that described in U.S. Pat. No.4,801,494 to Datta et al (directed toward a non-woven absorbent fabricthat provides fast absorbency of bodily exudates for use as a liner infeminine napkins, absorbent garments, diapers, etc.).

Holden, U.S. published Patent Application 2004/0006814 disclosesprotective peel and stick adhesive pad attachments for protection anddecoration that removably attach to the bottom of the human foot, to thehuman hands, elbow, knees, shins, and also to animal foot pads, in asnug tight fit. These pads offer foot protection for walking at thebeach or poolside, and may be used in some sports such as surfing,swimming, beach volleyball, river rafting, boating, dance, aquaaerobics, and gymnastics. The adhesive used by Johnson & Johnson in itshydrocolloid adhesive Band-Aid® Callus Relief product featuring Compeed®Moisture Seal™ Technology is among the preferred adhesives. The adhesiveused in Dr. Scholl's® Waterproof Corn Cushions is more preferred,especially for applying toe pieces on the bottoms of the toes. MSX 5527PU acrylate adhesive tape with polyurethane backing by 3M is mostpreferred, especially for applying toe pieces on the bottoms of thetoes.

Examples of Existing Pressure Sensitive Adhesive Tapes

There are also several patents that are directed toward industrialpressure sensitive adhesive (PSA) tapes for industrial applicationshaving high tensile strength that meet Underwriter Laboratoriesrequirements and the ASTM technical standards and testing methods fortheir particular class of tapes. These industrial tapes are supplied inrolls and are not particularly suitable for orthopedic use or forapplication to human skin.

For example, Desnoyers, U.S. Pat. No. 3,482,683 discloses a thinflexible normally tacky pressure sensitive bundling tape havingrelatively high longitudinal extensibility and high resistance tocrosswise tearing forces which will not delaminate, split or fibrillatewhen unwound from a roll. The tape comprises a relatively thin backingfilm, a normally tacky and pressure-sensitive adhesive coating on onesurface of the backing film and a delamination resistant secondary layerunited to the other surface of the backing film. The backing filmcomprises a hypermolecularly oriented linear crystalline polyolefin filmconsisting essentially of molecular chains that are predominantlyoriented lengthwise of the tape in the form of a series oflongitudinally extending fibrous polyolefinic elements which arecoherently assembled in the film and undistinguishable to the naked eye.The hypermolecularly oriented backing film has a tensile strength in thelengthwise direction of at least about 20,000 psi and a ratio oflengthwise elongation at break to crosswise elongation at break of atleast about 10 to 1 and a ratio of lengthwise tensile strength tocrosswise tensile strength of at least about 3 to 1. The delaminationresistant secondary layer has a lengthwise resistance to tearing that isgreater than the lengthwise resistance to tearing of the backing film.

Huddleston et al, U.S. Pat. No. 4,997,709 discloses an adhesive foiltape for use with rigid fiberglass air ducts that meets UnderwriterLaboratories, Inc. 181A requirements and specifications for aluminum oraluminum foil tapes for use with rigid fiberglass air ducts, and theapplicable ASTM technical standards and testing methods outlined in ASTMD3759, ASTM 3330, and ASTM D3654. The tape has a metal foil backingcarrying a layer of an adhesive composition consisting essentially of:(1) 100 phr of a block copolymer consisting of from 75 to about 100parts by weight of a styrene-isoprene-styrene triblock copolymer andfrom 0-25 parts by weight of a member selected from the group consistingof a styrene-isoprene diblock copolymer, a styrene-butadiene-styrenetriblock copolymer and a mixture of styrene-isoprene diblock copolymerand styrene-butadiene-styrene triblock copolymer; (2) from about 60 toabout 110 phr of rubber phase associating resin; (3) from about 5 toabout 30 phr of a polyestyrene phase associating resin; (4) an effectiveamount of flame retardant; (5) an effective amount of antioxidant forthe rubbery isoprene moiety; and (6) a crosslinking system forcrosslinking the isoprene moiety.

SUMMARY OF THE INVENTION

The present invention overcomes the aforementioned problems and isdistinguished over the prior art in general, and these patents inparticular by a disposable two-part orthotic foot support strap systemhaving a sole support strap member and an arch support strap member thatcan be adhesively applied to a foot individually or in combination forreducing tensile loads and stresses and providing anatomical support andstability to the musculoskeletal system and the sole, arch and heel of afoot of a user, and relief from plantar fasciitis. The sole supportstrap is a preformed elongate generally rectangular ultrathin strapformed of flexible, non-resilient non-stretch woven material having anadhesive layer on an underside surface thereof, the underside surfacehaving a contiguous ball of foot portion, a midfoot portion, and a heelportion adapted to be adhered to, and extend along, the ball of thefoot, the midfoot, and the heel of the user's foot, and conform to thecurvature thereof. In a preferred embodiment, a pair of elongatelaterally spaced heel tabs extend rearwardly from the heel portion to beadhered to the back side and lateral sides of the back of the user'sheel in crossed over relation to one another to form a generallycup-shaped cradle configuration conforming to the contours of the backside of the user's heel to prevent slippage of the sole support strap.The arch support strap is a preformed elongate generally rectangularultrathin strap formed of flexible, non-resilient non-stretch wovenmaterial having an adhesive layer on an underside surface thereofadapted to be adhered transversely over the midfoot portion of the solesupport strap and at least a portion of opposed sides of the arch of theuser's foot and conform to the curvature thereof.

In a preferred embodiment, the non-stretch woven material is a wovenmaterial formed of synthetic microfibers, and has a tensile strengthsufficient to prevent stretching and elongation of the sole supportstrap and the arch support strap in a longitudinal and transversedimension, and the adhesive layer of each has a tack strength sufficientto prevent slipping or creeping.

In the adhered condition on the skin surfaces of the foot, the solesupport strap flexes with the foot, and when subjected to cyclic loadingand stresses during phases of a walking gait cycle, functions as atensile load bearing member, in the manner of an external ligament, inthe region between the ball of the foot and the heel of the foot toreduce fascia stress throughout the gait cycle, and particularly peaktensile loads and stresses in the plantar fascia by maintaining anessentially constant distance between the ball of the foot and the heelof the foot during a heel contact phase, a weight bearing midstancephase, and a propulsion (toe-off or lift-off) phase of the walking gaitcycle so as to bear major tensile loads and stresses, which wouldotherwise be absorbed primarily by the plantar fascia as forces on thefoot attempt to flatten the arch. The arch support strap, when used incombination with the sole support strap, in the adhered condition,maintains the sole support strap in adhesive engagement with the sole ofthe user's foot and provides additional support to the arch and the bonestructure of the user's foot to reduce tension and stretching of thearch and plantar fascia during the pronation and propulsion phases ofthe gait cycle. The arch strap functions synergistically with the solestrap. Encircling the mid-foot, with the arch strap over the sole strapprevents the sole strap from pulling loose in the arch area of themid-foot as the arch strap is under tension, thus assisting the solestrap in functioning in a manner much like the underlying plantarfascia. The non-stretch material of the arch strap and slip resistantbond with the skin surface enables it to provide direct support to thearch and to the stabilize the bones of the mid-foot. The arch supportstrap may also be used alone to provide stability and support to thearch and the bone structure of the user's foot to reduce tension andstretching of the arch and plantar fascia during the pronation andpropulsion phases of the gait cycle.

The ultra-thin non-stretch materials of the sole support and archsupport straps allow them to be applied without adding bulk or applyingcirculation constraining compression. The non-slip adhesive bond allowsstrain on the foot to be transferred via the skin layer to thenon-stretch material thus providing a ligament-like level of support.

One of the significant features and advantages of the present footsupport strap system is that that the sole support strap functions as atensile load bearing member, in the manner of an external ligament, inthe region between the ball of the foot and the heel and, because it issecurely affixed and substantially inelastic, effectively reduces fasciastress through the entire gait cycle, and particularly reduces peakstress in the plantar fascia by maintaining the distance between theball of the foot and the heel of the foot constant during the heelcontact phase, the weight bearing midstance phase, and the propulsion(toe-off or lift-off) propulsion phase of the walking gait cycles; thus,bearing or sharing major tensile loads and stresses, which wouldotherwise be absorbed primarily by the plantar fascia, and the fasciaand surrounding tissues across both the medial and longitudinal arches,to prevent damage to the fascia and allows damaged fascia to heal.

Another feature and advantage of the present foot support strap systemis that the arch support strap may be used in combination with the solesupport strap to effectively maintain the sole support strap in adhesiveengagement with the sole of the foot and prevent it from pulling loosein the arch area of the foot, or may be used alone to provide anatomicalstructural support to the arch, the mid-foot, and the bone structure ofthe foot, to limit pronation or prevent over pronation of the foot.

Another feature and advantage of the invention is that the sole supportstrap restricts extension of the tissue on the bottom of the foot tosignificantly reduce the level of tensile stress on the plantar fasciato reduce foot pain, arch pain, and heel pain, and rehabilitate theplantar fascia, and prevent further injury to the plantar fascia

Another feature and advantage of the invention is that the sole supportstrap includes heel tabs that, in a preferred embodiment, can be adheredto the back side and lateral sides of the back of the heel in a crossedconfiguration to provide a generally cup-shaped cradle for the heel,provide resistance to slippage, and when bonded to the outer skinsurface at the back of the heel directs tensile stresses around and awayfrom the center of the heel to protect an area of the plantar mostlikely to be injured.

Another feature and advantage of the invention is that it providesdurable support and minimizes plantar stresses through the entirewalking gait cycle and allows a user to limit stress on the foot whilecontinuing with most normal activities, including running, sports andother activities.

Another feature and advantage of the invention is that the sole supportstrap restricts extension of the tissue on the bottom of the foot tosignificantly reduce the level of tensile stress on the plantar fasciato reduce foot pain, arch pain, and heel pain, and rehabilitate theplantar fascia, and prevent further injury to the plantar fascia

Another feature and advantage of the invention is that the sole supportstrap and the arch support strap are ultrathin and closely conform tothe shape and contours of the foot, and can be worn alone or incombination inside shoes, socks and hose without being easily detectedor causing uncomfortable bulk, and can also be worn while using otherfoot support devices such as arch supports, night splints, and customorthotics.

Another feature and advantage of the invention is that the sole supportstrap and the arch support strap employ woven microfiber materials andhigh tack strength adhesive which allow them to be worn for many hoursduring normal and rigorous activities, without deforming or slippingposition on the skin surface.

Another feature and advantage of the invention is that the wovenmicrofiber material substantially prevents stretching and elongation ofthe sole support strap and spreads shear stresses over a large surfacearea without exceeding the adhesive limits of the adhesive.

Another feature and advantage of the invention is that the sole supportstrap and arch support straps are preformed and shaped and sized to fitmost foot sizes without modification, are easily and quickly installedby the user and, if desired, can be easily trimmed with a pair ofscissors to fit a particular user or foot irregularity.

Another feature and advantage of the invention is that the support strapsystem may worn by a user who is not currently experiencing pain, butanticipates the potential for injury during a strenuous activity orexercise, and wishes to avoid overstressing the plantar fascia.

Another feature and advantage of the invention is that the sole and archstraps are preformed, pre-cut and pre-shaped and include removable coversections over their adhesive layer enabling easy and consistent selfapplication without handling adhesive surfaces by an end user, andwithout requiring special training, professional skills, extensivemodification, or use of tools.

Another feature and advantage of the invention is that the sole and archstraps are preformed and shaped for universal application to a right orleft foot, and provide ease and consistency of self-application.

Another feature and advantage of the invention is that it provides amethod of treating heel pain and plantar fasciitis by limiting damagingstress in the fascia through the entire walking cycle and for extendedperiods of time from hours per day to multiple days in a row, both attimes with and without footwear thus allowing the fascia a therapeuticduration of rest in order for healing to occur uninterrupted by hightensile stress.

Another feature and advantage of the invention is that it can be use bya person who is not currently experiencing pain, but anticipates thepotential for injury during a strenuous activity or exercise, and wishesto avoid overstressing the plantar fascia.

A further feature and advantage of the present invention is that thelevel of support provided by the system can be easily adjusted by a userby altering the degree of dorsal flexion about a 90° (neutral dorsalflex) position during application in order to produce the desired levelof support.

A still further feature and advantage of the invention is that thesupport strap system is simple in construction, inexpensive tomanufacture, and extremely rugged and durable in use.

Other features and advantages of the invention will become apparent fromtime to time throughout the specification and claims as hereinafterrelated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration showing parts of a plantar fascia in adissected bottom view of a human foot.

FIG. 2 is a cross sectional side view showing the tissue and bonestructure in the human foot.

FIG. 3 is a perspective view of the sole support strap member and archsupport strap member of the disposable two-part non-resilient,non-stretch orthotic foot support strap system in accordance with thepresent invention removably adhered to the front side of a release linersheet.

FIG. 4 is a perspective view of the back side of the release liner sheetshowing the perforated line extending between the sole support strap andthe arch support strap and the transverse cuts that extend across theunderside of the sole support strap and arch support strap.

FIGS. 5A, 5B, and 5C are a front elevation view, a side view, and a rearelevation view, respectively, of the sole support strap.

FIG. 5D is an enlarged detail of a portion of the sole support strapshowing, somewhat schematically, the warp and weft pattern of thenon-stretch woven material of the sole support strap.

FIGS. 6A, 6B, and 6C are a front elevation view, a side view, and a rearelevation view, respectively, of the arch support strap.

FIGS. 7A through 7H are illustrations showing the steps of separatingand removing the sole support strap and the arch support strap, applyingthe sole support strap to the sole of a wearer's foot, adjusting thetension, securing the heel tabs, and applying the arch support straparound the arch and over the outside of the foot sole support strap, oraround the arch of the foot.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is a disposable two-part non-resilient,non-stretch orthotic foot support strap system having a sole supportstrap member 10 and an arch support strap member 20 that can beadhesively applied to a foot individually or in combination to reducetensile loads and stresses and provide anatomical support and stabilityto the musculoskeletal system and the sole, arch, and heel of a foot ofa user, and relief from plantar fasciitis.

Referring now to FIGS. 3 and 4, in a preferred embodiment, the solesupport strap 10 and the arch support strap 20 are removably adhered toa generally rectangular release liner sheet 30 in laterally spacedrelation. The release liner sheet 30 is formed of thin paper or plasticfilm coated on one side with a release agent, such as for examplesilicone, and the adhesive side of the sole support strap 10 and thearch support strap 20 are adhered to the coated side of the releaseliner sheet. The construction of the sole support strap 10 and the archsupport strap 20 and their structural properties will be described indetail hereinafter.

The release liner backing sheet 30 may be perforated along a straightline 31 extending longitudinally from end to end between the solesupport strap 10 and the arch support strap 20 to provide separatereleasable portions 30A and 30B, and provided with a transverse cut 32that extends between the longitudinal sides of the sheet.

The perforated line 31 allows the sole support strap 10 and the archsupport strap 20 to be separated but still adhered to respectivelongitudinal portions 30A, 30B of the release liner sheet 30, and with arespective transverse cut 32 extending across the adhesive side of thesole support strap 10 and the arch support strap 20 intermediate theiropposed ends. The separated portions of the of the release liner backingsheet 30 prevent accidental adhesion prior to use. The cut 32 definesfirst and second shorter segments 30C and 30D of the longitudinalportions of the release liner sheet 30, that can be removed individuallyfrom the adhesive side of the sole support strap 10 and the arch supportstrap 20, respectively, as described hereinafter. The release linerbacking sheet 30 may formed of various commercially available releaseliner materials such as for example, but not limited thereto, a 3.5 mil60 lb. KRAFT™ release liner paper.

It should be understood that, alternatively, the sole support strap 10and the arch support strap 20 may be provided individually with eachadhered to a respective longitudinal strip of a release liner sheet 30with each strip having a respective transverse cut 32 extending acrossthe adhesive side of the sole support strap 10 and the arch supportstrap 20 defining first and second shorter segments 30C and 30D of thelongitudinal release liner sheet 30, that can be removed individuallyfrom the adhesive side of the sole support strap and arch support strap.

Referring now to FIGS. 5A, 5B, and 5C of the drawings by numerals ofreference, there is shown, a preferred sole support strap member 10formed of an ultrathin ply of flexible, non-resilient non-stretch wovenmaterial 11 having an adhesive layer 12 on one side (described in detailhereinafter). The sole support strap 10 is preformed and has anelongated, generally rectangular shape preferably with rounded corners.The underside of the sole support strap 10 includes a front end 13, anda contiguous ball of foot area 14, mid-sole area 15, and heel area 16,with integrally formed laterally spaced apart heel tabs 17 extending adistance rearwardly from the heel area. Preferably, each of the heeltabs 17 has a generally rectangular configuration with rounded outerends, and are disposed in parallel relation separated by an inwardlyextending cut 18. It should be understood that, alternatively, the heeltabs 17 may be formed as a single strip perforated along a centralstraight line, and manually divided. It should also be understood thatthe heel tabs 17 may be of other configurations, and may not beparallel.

In a preferred embodiment, for use by an adult, the sole support strap10 has an overall length in the range of from about 6.0 inches to 14.0inches, more preferably, in the range of from about 9 inches to 12inches, and most preferably a length of about 10 to about 11.5 inches.

In a preferred embodiment for use by an adult, the sole support strap 10has a width in the range of about 1 inch to about 3.5 inches, morepreferably, in the range of from about 2.0 inches to about 3.00 inches,and most preferably a width of about 2.25 inches. The sole support strap10 does not need to be as wide as a user's foot nor cover the entirefascia of the user to be effective. Preferably, the sole support strap10 has a length to width ratio greater than 2.5, more preferably, aratio greater than 3.5, and most preferably a ratio of about 4.5.

The heel tabs 17 are preferably of a length in the range of from about1.0 inches to about 6.0 inches, more preferably a length of about 3.0inches to about 4.0 inches, and most preferably a length of about 3.75inches, or a length of about one-third the length of the sole supportstrap 10. Each heel tab 17 has a width in the range of about 0.375inches to about 1.75 inches, more preferably, in the range of from about0.875 inches to about 1.5 inches, and most preferably a width of about 1inch.

As described hereinafter, when applied to the user's foot, the solesupport strap 10 extends along the sole of the foot from the ball of thefoot to the heel, excluding the toes, and the heel tabs 17 are crossedover the back side and lateral sides of the back of the foot forming acradle to support the heel and further insure against slippage. Thedivided heel tabs allow the sole support strap 10 to be used on a widerange of foot sizes. The heel tabs will simply extend further up theback of a smaller foot and extend less on larger feet.

Referring additionally to FIGS. 6A, 6B, and 6C, the arch support strapmember 20 may be used in combination with the sole support strap member20 to supplement and further aid in supporting the foot and particularlythe plantar fascia, and to minimize pronation of the foot. The archsupport strap 20 when applied transversely around and over the outsideof the foot sole support strap member 10 is effective in maintaining thesole support strap 10 in adhesive engagement with the sole of the foot,and prevents it from pulling loose in the arch area of the foot, thusassisting the sole support strap member in maintaining proper tension.The arch support strap 20 is also effective in limiting pronation orpreventing over pronation, as it provides support to the arch and thebone structure of the foot. The arch support strap 20 may also be usedalone without sole support strap 10 to provide anatomical support to themid-foot foot and particularly to prevent or limit pronation.

The arch support strap 20 is formed of formed of an ultrathin play offlexible, non-resilient non-stretch woven material 21 having an adhesivelayer 22 on one side (described in detail hereinafter). The arch supportstrap 20 is precut and has an elongated, generally rectangular shapepreferably with rounded corners.

In a preferred embodiment, the arch support strap member 20 has a lengthin the range of from about 6 inches to about 14 inches, more preferably,in the range of from about 9 inches to about 12 inches, and mostpreferably a length of about 10 to about 11.5 inches. In a preferredembodiment for use by an adult, the arch support strap 20 has a width inthe range of about 0.75 inch to 3.5 inches, more preferably, in therange of from about 1.0 inches to about 3.0 inches, and most preferablya width of about 1.5 inches to about 1.75 inches. The arch support strap20 may wholly encircle the arch area of the foot, but does not need tocover the entire arch.

The preformed generally rectangular configuration of the sole supportstrap 10 and arch support strap 20 is preferable because it allows themto be used universally on either a left foot or a right foot. Therectangular shape also provides ease of use and of manufacture. Therounded corners are preferable because they significantly reduce oreliminate the possibility of the corners becoming snagged andaccidentally peeling up. It should be understood, however, that the solesupport strap 10 and arch support strap 20 may be provided in othershapes and dimensions. They may also be easily cut or trimmed by theuser into a desired shape for a particular preference.

A preferred material suitable for use in constructing the ultrathin plyof flexible, non-resilient non-stretch ply of woven material 11 and 21of the sole support strap 10 and the arch support strap 20 is a wovenmicrofiber using synthetic microfibers, such as, for example rayonmicrofibers, wherein both the warp (lengthwise) and weft (crosswise)microfibers (FIG. 5D) are substantially inelastic; consequently, thewoven material is substantially non-stretchable beyond its originaldimensions in a longitudinal and transverse direction. The ultrathin plyof woven material 11 and 21 of the sole support strap 10 and the archsupport strap 20 has a thickness less than 1 mm; preferably in a rangeof between about 5 mils (0.127 mm or 0.005 inch) to about 30 mils (0.762mm or 0.030 inch), and most preferably less than 15 mils (0.381 mm or0.015 inch). This woven microfiber material has a tensile strength inexcess of 70 lb/in-width and a ratio of elongation-to-tensile strengththat is less than nine tenths (0.9) to provide a balanced combination ofstrength and resistance to elongation. It should be understood thatother flexible non-resilient non-stretch woven materials having thesesame or substantially the same physical properties may be used.

The thin flexible non-resilient non-stretch material of the sole supportstrap 10 and the arch support strap 20 may also be breathable. Forexample, the material may have a moisture vapor transfer rate (MVTR) ofat least 100 g/24 h/m². The flexible non-resilient non-stretch materialof the sole support 10 and the arch support strap 20 may also be ahypo-allergenic material.

The pressure sensitive adhesive layer 12 of the sole support strap 10and adhesive layer 12 of the arch support strap 20 is a high holdingstrength adhesive of sufficient tack strength so as to adhere the solesupport strap 10 and arch support strap 20 to the user's foot duringperiods of activity but allow them to be removed without damage to theuser's skin. A preferred pressure sensitive adhesive suitable for use isan adhesive having a 180° peel strength equal to, or greater than, 15oz/in when tested in accordance with the Pressure Sensitive Tape Council(PSTC) PSTC-3 Standard Adhesion to Steel 180° Peel Test. The preferredadhesive is also hypo-allergenic and non-irritating to the skin.Preferably, the adhesive layer 12, 22, is less than 3.5 mils (0.0889 mmor 0.0035 inch) thick. The adhesive 12, 22, allows the sole supportstrap 10 and the arch support strap 20 to be easily removed andreadjusted by pulling the support strap member in a direction away fromthe skin surface, such as when pulled at a ninety-degree angle from theskin surface. The adhesive having these properties is highly resistantto shear stresses and will not allow the foot support strap 10 and archsupport strap 20 to slip or creep under cyclic loading and stressesduring use.

The combined thickness of the non-resilient non-stretch woven material11, 21, and adhesive layer 12, 22, is less than 1 mm; preferably in arange of between about 5 mils (0.127 mm or 0.005 inch) to about 30 mils(0.762 mm or 0.030 inch), and most preferably less than 15 mils (0.381mm or 0.015 inch).

The thin flexible non-resilient non-stretch woven material 11, 21, andadhesive 12, 22, of the sole support strap 10 and the arch support strap20 meets the ASTM technical standards and testing conditions outlined inASTM D3759, exhibiting less than 15% elongation when subject to a 25pound tensile load. The sole support strap 10 and the arch support strap20 each preferably have a ratio of elongation-to-tensile strength(lb/in-width) that is less than nine tenths (0.9) to provide a balancedcombination of strength and resistance to elongation.

Preferably, the tensile strength (lb/in-width) of the sole support strap10 and the arch support strap 20 is greater than 15 lb/in-width and morepreferably greater than 25 lb/in-width. During use, the forces on thesole support strap 10 may exceed 15 lbs, and the sole support strap 10and the arch support strap 20 will exhibit less than 3% or no elongationwhen adhered to a user's foot and therefore would be essentiallyinelastic along its longitudinal and transverse axis when subjected to a15 lb force and not capable of being deformed elastically, elongated,lengthened, widened, or distended by stretching under the applied footloads and stresses during the phases of the walking cycle.

Thus, the inelastic non-stretch properties of the woven microfibermaterial 11, 21, of the sole support strap 10 and the arch support strap20 combined with the “adhesion” and “peel strength” properties of theadhesive 12, 22, provide a sole support strap 10 and arch support strap20 that are highly resistant to shear stresses, and will not tear,stretch or elongate, and will not slip or creep under cyclic loading andstresses during the phases of the walking cycle. When properly applied,the sole support strap 10, functions as a tensile load bearing member,in the manner of an external ligament, in the region between the ball ofthe foot and the heel. Because the sole support strap 10 issubstantially inelastic or non-stretchable, it effectively reducesfascia stress through the entire gait cycle, and particularly reducespeak stress in the plantar fascia by maintaining the distance betweenthe ball of the foot and the heel of the foot constant during the heelcontact phase, the weight bearing midstance phase, and the propulsion(toe-off or lift-off) propulsion phase of the walking gait cycles; thus,bearing or sharing major tensile loads and stresses, which wouldotherwise be absorbed primarily by the plantar fascia, and the fasciaand surrounding tissues across both the medial and longitudinal arches,to prevent damage to the fascia and allows damaged fascia to heal. Theelasticity of the skin surfaces at the back of the heel to which thecrossed heel tabs 17 are adhered aid in preventing the non-stretch solesupport strap 10 from slipping or pulling loose under the applied footloads.

The arch support strap 20, when used in combination with the solesupport strap 10, is adhered transversely over the outside of the footsole support strap member 10, and at least partially over the sides ofthe arch, and is effective in maintaining the sole support strap 10 inadhesive engagement with the sole of the foot and prevents it frompulling loose in the arch area of the foot, thus assisting the solesupport strap member in maintaining proper tension, and also supplementsand further aids in supporting the foot and particularly the plantarfascia, and minimizes pronation of the foot (rotation of the medialbones in the midtarsal region of the foot inward and downward). Whenused alone, the arch support strap 20 is adhered transversely under thearch of the foot and at least partially around the outer sides thereof,and provides anatomical structural support to the arch, the mid-foot,and the bone structure of the foot, and limits pronation or preventsover pronation.

The flexibility and extreme thinness features of the sole support strap10 and the arch support strap 20 allow them to conform to the shape andcontours of the human foot, and also allows them to be worn alone or incombination inside shoes, socks and hose without being easily detectedor causing uncomfortable bulk. The present orthotic foot support systemallows a user to limit stress on the foot while allowing the user tocontinue with most activities, including running, sports and otheractivities. The support strap system can also be worn while using otherfoot support devices such as arch supports, night splints, and customorthotics.

Application to the Foot

Referring now to FIGS. 7A-7G, the method of applying the sole supportstrap 10 and the arch support strap 20 to the foot will be described.For best results, it is recommended that the foot be washed andthoroughly dried prior to application and that the user be seated toapply the straps.

The release liner backing sheet 30 is torn along the longitudinalperforated line 31 to separate the respective first and secondlongitudinal portions 30A, 30B with the sole support strap 10 and thearch support strap 20 still adhered to the respective longitudinalportions release liner sheet (FIG. 7A).

The first longitudinal portion 30A of the release liner backing sheetbearing the sole support strap 10 is bent along the transverse cut 32 soas to expose the facing edges of the first and second shorter segments30C and 30D of the longitudinal release liner backing sheet portion 30A.The edge of the first shorter segment 30C is gripped and peeled off toexpose the adhesive side of the sole support strap 10 (FIG. 7B).

The front or ball of foot portion of the sole support strap 10 ispressed onto the ball of the foot just behind the toes. It is beneficialthat this portion be applied first, as it allows the tension in the solesupport strap to be preloaded as described hereinafter. With the solesupport strap 10 attached to the ball of the foot, the foot ispositioned at neutral 90° angle or slightly downward. The degree ofdownward angle affects the level of tension and degree of support to beafforded by the sole support strap. The second shorter segment 30D ofthe longitudinal release liner backing sheet portion 30A is gripped andpeeled off to expose the adhesive side of the remaining portion of thesole support strap 10 (FIG. 7C).

If the sole support strap 10 is applied while the foot is in dorsalflexion, the resulting tension of the sole support strap will be low. Ifthe sole support strap is applied in plantar flexion, the resultingtension will be higher as the foot tries to straighten out. Thus, thetension can be adjusted by the position of the foot while the solesupport strap is being applied to the foot.

More specifically, the method of controlling tension in the supportstrap system includes (1) holding ones foot in a generally neutral flexposition (about a 90° angle relative to the shinbone) during applicationof the sole support, particularly as it is being adhered along thelongitudinal axis of the foot; and/or (2) increasing the angle (plantarflexion) or decreasing the angle (dorsal flexion) to an alternativeangle correspondingly increasing or decreasing the desired degree ofsupport provided by the sole strap. Alternately, one may apply the solestrap, take a step to test the degree of support, then detach andreapply the arch strap with the desired pre-tension by adjusting theangle or degree of flexion. The initial degree of flexion is preferably90° degrees plus or minus 15° degrees. The degree of plantar flexionabove 90° is preferred to much less than 30 degrees, for a resultantangle typically not exceeding 120° degrees.

The adhesive side of the remaining portion of the sole support strap 10is pressed onto the mid-sole and heel of the foot with the heel tabs 17extending beyond the back of the heel (FIG. 7D). The divided heel tabsallow the sole support strap to be used on a wide range of foot sizes.The heel tabs will simply extend further up the back of a smaller footand extend less on larger feet. If necessary the heel tabs 17 may be cutwith a pair of scissors to adjust the length to fit the particularuser's foot.

The heel tabs 17 are raised upwardly and pressed onto the back side andlateral sides of the back of the heel in a crisscross manner over oneanother (FIG. 7E). The crossed heel tabs form a cradle to support theheel and a sound structure to prevent possible slippage. The crossedheel tabs and cradle route stresses around the center of the heel of thefoot to reduce direct pressure on the area of the plantar that is mostlikely to be injured. The sole support strap 10 is then pressed firmlyonto the sole and arch of the foot along its length to ensure adhesion.If necessary, the user may take a step and adjust the position of thesole support strap 10 and/or the heel tabs.

The arch support strap 20 is applied by bending the second longitudinalportion of the release liner backing sheet bearing the arch supportstrap along the transverse cut so as to expose the facing edges of thefirst and second shorter segments of the longitudinal release linerbacking sheet portion, and peeled off to expose the adhesive side of thearch support strap 20, in the same manner as described above withreference to the sole support strap. As shown in FIGS. 7F and 7G, themid portion of the arch support strap 20 is placed transversely over theoutside of the foot sole support strap member 10 near the middle of thearch and pressed down and the outer sides of the outer ends of the archsupport strap are wrapped at least partially over the sides of the archand pressed down. The outer ends of the arch support strap may or maynot overlap on the top of the foot. As discussed above, and as shown inFIG. 7H, the arch support strap 20 when used alone, is adheredtransversely under the arch of the foot and at least partially aroundthe outer sides thereof to provide anatomical structural support to thearch, the mid-foot, and the bone structure of the foot, and limitpronation or prevent over pronation.

After the sole support strap 10 and/or the arch support strap 20has/have been secured to the foot, it/they may be worn all day long evenduring the load bearing hours of the day, to reduce plantar fasciastress, and thus allow the fascia to rest and recover naturally, andshould be removed and discarded on a daily basis. If the user's skin issensitive or if the product seems difficult to remove, warm water may beapplied to aid in removal. Any adhesive residue left on the skin may beremoved with warm water and a wash cloth.

A preferred treatment method or regimen for treating arch pain, heelpain, or plantar fasciitis recovery, comprises the following steps: (1)adhesively applying the ultrathin, non-stretch foot support strap systemto the foot, as described above, to provide anatomical support to thefoot, (2) wearing the foot support strap system during active hours ofthe day (i.e. anytime while walking or standing), preferably for atleast 4-8 hours a day, and most preferably of the bulk of all loadbearing hours of the day, which for most individuals is a rangeaveraging 8-24 hours per day, and (3) repeating the process for a periodof days; preferably for 3-6 days at a minimum, and most preferably for6-12 days with all days being consecutive. The used straps should beremoved and discarded, and replaced with new supports as required tomaintain effectiveness and cleanliness.

Alternatively, the user or medical advisor may monitor heel pain levelsand continue to apply and use the foot support strap system for a periodof days after a significant decrease in heel pain has occurred, in orderto allow any previously damaged fascia time to strengthen. Many userswill experience pain reduction within 1-5 days. Lack of pain does notnecessarily signify that fascia is completely healed and is strongenough to withstand high impact or high stress activities. The preferredtreatment modality, as stated above, is to advise the user to continueto wear the support strap system for a period of days, preferably in arange from 1-6 days after the pain has subsided to allow the fascia tofully recover.

It should be understood that step (1), above, may include use of thearch support strap or sole support strap individually or in combination.The foot support strap system may be packaged to corresponded to therecommended treatment cycle, for example, a package may include a supplyof six sole support straps and six arch support straps corresponding toa six day treatment cycle for a single foot.

Referring again to FIG. 2, a sole support strap member 10 and an archsupport strap member 20 of the present two-part non-resilient,non-stretch orthotic foot support strap system, illustrated somewhatschematically and with a greater thickness for visibility, are shownattached to the sole of the foot 100. As described previously withreference to FIG. 2, the stress line 300 shows an approximation of theline of forces transferred through the foot 100 during typical motion.The stress line 300 resembles the shape of an archer's bow, and theplantar fascia 110 running along near the bottom surface of the foot 100is analogous to the string in the archer's bow. Forces that tend to movethe ends of the bow apart increase tension on the string. In otherwords, as forces on the arch push the bones downward, the plantar fascia110 is subjected to tensile forces.

When adhered to the bottom of the foot, as described previously above,the sole support strap 10 is analogous to another string in the archer'sbow connected in parallel with the plantar fascia 110. The sole supportstrap 10 functions as a tensile load bearing member, in the manner of anexternal ligament, in the region between the ball of the foot and theheel and, because it substantially inelastic or non-stretchable, iteffectively reduces fascia stress through the entire gait cycle, andparticularly reduces peak stress in the plantar fascia by maintainingthe distance between the ball of the foot and the heel of the footconstant during the heel contact phase, the weight bearing midstancephase, and the propulsion (toe-off or lift-off) propulsion phase of thewalking gait cycles; thus, bearing or sharing major tensile loads andstresses, which would otherwise be absorbed primarily by the plantarfascia, and the fascia and surrounding tissues across both the medialand longitudinal arches, to prevent damage to the fascia and allowsdamaged fascia to heal.

The arch support strap 20, when used in combination with the solesupport strap 10, is adhered transversely over the outside of the footsole support strap member 10, and at least partially over the sides ofthe arch, and is effective in maintaining the sole support strap 10 inadhesive engagement with the sole of the foot and prevents it frompulling loose in the arch area of the foot, thus assisting the solesupport strap member in maintaining proper tension, and also supplementsand further aids in supporting the foot and particularly the plantarfascia, and minimizes pronation of the foot (rotation of the medialbones in the midtarsal region of the foot inward and downward). Whenused alone, the arch support strap 20 is adhered transversely under thearch of the foot and at least partially around the outer sides thereof,and provides anatomical structural support to the arch, the mid-foot,and the bone structure of the foot, and limits pronation or preventsover pronation.

Although the present invention has been shown and described as adisposable two-part non-resilient, non-stretch orthotic foot supportstrap system that can be adhesively applied to a foot to reduce tensileloads and stresses and provide anatomical support and stability to themusculoskeletal system and the sole, arch, and heel of a foot of a user,and relief from plantar fasciitis, it should be understood, that thepresent invention may have therapeutic uses to reduce tensile loads andstresses and provide anatomical support and stability to themusculoskeletal system of other parts of the body, where ligament-likesupport is beneficial.

While the present invention has been disclosed in various preferredforms, the specific embodiments thereof as disclosed and illustratedherein are considered as illustrative only of the principles of theinvention and are not to be considered in a limiting sense ininterpreting the claims. The claims are intended to include all noveland non-obvious combinations and sub-combinations of the variouselements, features, functions, and/or properties disclosed herein.Variations in size, materials, shape, form, function and manner ofoperation, assembly and use, are deemed readily apparent and obvious toone skilled in the art from this disclosure, and all equivalentrelationships to those illustrated in the drawings and described in thespecification are intended to be encompassed in the following claimsdefining the present invention.

1. A method for treating plantar fasciitis and foot pain by reducingtensile loads and stresses in the plantar fascia and providing supportto a foot of a user, comprising the steps of: providing a pre-cut solesupport strap formed of woven material having an adhesive layer on anunderside surface thereof covered by a removable release liner sheet,said underside surface having a contiguous ball of foot portion and aheel portion, said adhesive layer having an adhesive strength sufficientto prevent slippage of said sole support strap when secured to skinsurfaces of the foot and exposed to stresses imposed by walking;removing said release liner sheet from said adhesive layer of said solesupport strap; and adhering said sole support strap to the skin surfacealong the sole of the foot from the ball of the foot to the heel of thefoot, and adhering said heel portion to the skin surfaces along the heeland the back and lateral sides of the heel of the foot; such that saidsole support strap, in the adhered condition, flexes with the foot andprovides stability and support to the user's foot and, when subjected tothe forces induced during walking, absorbs tensile loads and stresses toprevent damage to the plantar fascia by reducing tensile stress carriedby the plantar fascia.
 2. The method according to claim 1, comprisingthe further steps of: providing a pre-cut elongate arch support strapformed of woven material having an adhesive layer on an undersidesurface thereof covered by a removable release liner sheet; removingsaid release liner sheet from said adhesive layer of said arch supportstrap; and adhering said arch support strap transversely over said solesupport strap and to at least a portion of skin surfaces of opposedsides of a longitudinal arch portion of the foot; such that said archsupport strap, in the adhered condition, maintains said sole supportstrap in adhesive engagement with the sole of the user's foot and, whensubjected to the forces induced during walking, functions to provideadditional support to an anatomical arch of the user's foot to reducetensile loads and stresses in the plantar fascia as forces on the footattempt to flatten the arch.
 3. The method according to claim 1, whereinsaid step of adhering said sole support strap to the skin surface alongthe sole of the foot from the ball of the foot to the heel of the footcomprises: adhering said ball of foot portion of said sole support straponto the skin surface of the ball of the foot; positioning the foot in agenerally neutral flex position of about a 90° angle relative to theshinbone; and adhering said sole support strap to the skin surfacesalong the midfoot of the sole, the heel and the back and lateral sidesof the heel, while applying tension in said sole support strap.
 4. Themethod according to claim 1, wherein said step of adhering said solesupport strap to the skin surface along the sole of the foot from theball of the foot to the heel of the foot comprises: adhering said ballof foot portion of said sole support strap onto the skin surface of theball of the foot; selectively positioning the foot relative to a neutralflex position at an increased angle in a plantar flexion position or adecreased angle in a dorsal flexion position; and adhering said solesupport strap to the skin surfaces along the midfoot of the sole toconform to the curvature thereof, and adhering said heel portion to theskin surfaces along the heel and the back and lateral sides of the heelof the foot; whereby the resulting tension of said sole support strapwill be lower when applied while said foot is in the dorsal flexionposition, and the resulting tension of the sole support strap will behigher when applied while the foot is in the plantar flexion position,as the foot attempts to straighten out when subjected to weight bearingand when subjected to the forces induced during walking.
 5. The methodaccording to claim 1, wherein said heel portion of said sole supportstrap includes a pair of laterally spaced elongate heel tabs; and saidstep of adhering said heel portion to the skin surfaces along the heeland the back and lateral sides of the heel of the foot comprises:adhering said heel tabs to the back side and lateral sides of the backof the user's heel in crossed over relation to one another to form agenerally cup-shaped cradle configuration conforming to the contours ofthe back side of the user's heel to prevent slippage of said solesupport strap.
 6. The method according to claim 1, comprising thefurther steps of: maintaining said sole support strap in the adheredcondition on the sole of the user's foot for at least four hours,including periods when the user's foot is subjected to weight bearingand cyclic loading and stresses.
 7. The method according to claim 6,comprising the further steps of: removing the previously worn solesupport strap, adhering an unused sole support strap on the foot,maintaining said sole support strap in the adhered condition on the soleof the user's foot for at least four hours, including periods when theuser's foot is subjected to weight bearing and cyclic loading andstresses induced during walking; and repeating the process for at leastthree consecutive days.
 8. The method according to claim 7, wherein saidstep of repeating the process is carried out for a period of from aboutthree to about twelve consecutive days.
 9. The method according to claim1, comprising the further steps of: maintaining said sole support strapin the adhered condition on the sole of the user's foot for a period oftime in the range of from about four hours to about twenty-four hoursper day, including periods when the user's foot is subjected to weightbearing and cyclic loading and stresses induced during walking.
 10. Themethod according to claim 9, comprising the further steps of: removingthe previously worn sole support strap, adhering an unused sole supportstrap on the foot, maintaining said sole support strap in the adheredcondition on the sole of the user's foot for a period of time in therange of from about four hours to about twenty-four hours per day,including periods when the user's foot is subjected to weight bearingand cyclic loading and stresses induced during walking; and repeatingthe process for at least 3 consecutive days.
 11. The method according toclaim 10, wherein said step of repeating the process is carried out fora period of from about three to about twelve consecutive days.
 12. Amethod for treating foot pain by reducing tensile loads and stresses inthe plantar fascia and providing anatomical support and stability to themusculoskeletal system of a foot of a user, comprising the steps of:providing a pre-cut elongate arch support strap formed of woven materialhaving an adhesive layer on an underside surface thereof covered by aremovable release liner sheet, and said adhesive layer having anadhesive strength sufficient to prevent slippage of said arch supportstrap when secured to skin surfaces of the foot; removing said releaseliner sheet from said adhesive layer of said arch support strap; andadhering said arch support strap transversely to the skin surface of alongitudinal arch portion of the foot and to at least a portion of skinsurfaces of opposed sides of the longitudinal arch portion of the foot;such that said arch support strap, in the adhered condition, whensubjected to the forces induced during walking, functions to provideadditional support to an anatomical arch of the user's foot to reducetensile loads and stresses in the plantar fascia as forces on the footattempt to flatten the arch.
 13. The method according to claim 12,comprising the further steps of: maintaining said arch support strap inthe adhered condition on the user's foot for at least four hours,including periods when the user's foot is subjected to weight bearingand cyclic loading and stresses induced during walking.
 14. The methodaccording to claim 13, comprising the further steps of: removing thepreviously worn arch support strap, adhering an unused arch supportstrap on the foot, maintaining said arch support strap in the adheredcondition on the user's foot for at least four hours per day, includingperiods when the user's foot is subjected to weight bearing and cyclicloading and stresses induced during walking; and repeating the processfor at least three consecutive days.
 15. The method according to claim14, wherein said step of repeating the process is carried out for aperiod of from about three to about twelve consecutive days.
 16. Themethod according to claim 12, comprising the further steps of:maintaining said arch support strap in the adhered condition on theuser's foot for a period of time in the range of from about four hoursto about twenty-four hours per day, including periods when the user'sfoot is subjected to weight bearing and cyclic loading and stresses 17.The method according to claim 16, comprising the further steps of:removing the previously worn arch support strap, adhering an unused archsupport strap on the foot, maintaining said arch support strap in theadhered condition on the sole of the user's foot for a period of time inthe range of from about four hours to about twenty-four hours per day,including periods when the user's foot is subjected to weight bearingand cyclic loading and stresses; and repeating the process for at least3 consecutive days.
 18. The method according to claim 17, wherein saidstep of repeating the process is carried out for a period of from aboutthree to about twelve consecutive days.
 19. A method for providinganatomical support to the foot of a user, comprising the steps of:providing a pre-cut sole support strap formed of woven material havingan adhesive layer on an underside surface thereof covered by a removablerelease liner sheet, said underside surface having a contiguous ball offoot portion and a heel portion, and said adhesive layer having anadhesive strength sufficient to prevent slippage of said sole supportstrap when secured to skin surfaces of the foot and exposed to stressesimposed by walking; removing said release liner sheet from said adhesivelayer of said sole support strap; and adhering said sole support strapto the skin surface along the sole from the ball of the foot to heel,and adhering said heel portion to the skin surfaces along the heel andthe back and lateral sides of the heel of the foot; providing a pre-cutelongate arch support strap formed of woven material having an adhesivelayer on an underside surface thereof covered by a removable releaseliner sheet and removing said release liner sheet from said adhesivelayer of said arch support strap; and adhering said arch support straptransversely over said sole support strap and to at least a portion ofskin surfaces of opposed sides of a longitudinal arch portion of thefoot; wherein in the adhered condition said support straps provideanatomical support to the foot.
 20. The method according to claim 19,wherein said heel portion of said sole support strap includes a pair oflaterally spaced elongate heel tabs; and said step of adhering said heelportion to the skin surfaces along the heel and the back and lateralsides of the heel of the foot comprises: adhering said heel tabs to theback side and lateral sides of the back of the user's heel in crossedover relation to one another.